BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2251667 · Received August 10, 2011

    Report

    Report Number
    3004209178-2011-82496
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A FROZEN DISPLAY AND CONSTANT TONE AS A RESULT OF A CORRODED ELECTRONIC ASSEMBLY. DURING VISUAL INSPECTION WAS ALSO FOUND CORROSION ON THE MOTOR ASSEMBLY. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE FROZEN DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A FROZEN DISPLAY. TROUBLESHOOTING WAS PERFORMED. THE BUTTONS WERE UNRESPONSIVE AND THE INSULIN PUMP HAD A CONSTANT TONE. THE CUSTOMER STATED THAT THE BUTTONS DID BEGIN TO WORK INTERMITTENTLY AFTER THE BATTERY WAS CHANGED. ADVISED THE CUSTOMER TO INSERT NEW BATTERY, BUT THE INSULIN PUMP HAD AN ERROR ALARM AND THE BUTTONS STILL WERE UNRESPONSIVE. INSTRUCTED TO CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR